US FDA Approves New-and Very Potent-Painkiller, Despite Warnings

The drug approved Friday is a 30-microgram pill form of sufentanil, a powerful, 34-year-old opioid commonly used after surgery and in emergency rooms.

The U.S. Food and Drug Administration approved a powerful new opioid medication on Friday, in spite of major concerns raised by health advocates that the drug's strength and design could prove harmful for patients and the public.

Democratic Senator Ed Markey of MA urged the FDA not to approve Dsuvia last month, saying "an opioid that is a thousand times more powerful than morphine is a thousand times more likely to be abused, and a thousand times more likely to kill". Also, Dr. Palmer argues that risk for abuse is low because it must be administered-again, by a health care professional in a controlled medical center setting-under the tongue.

Critics are blasting the FDA for approving Dsuvia as the country faces increasing opioid overdose deaths. "It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly", Dr. Sidney Wolfe, founder and senior adviser of Public Citizen's Health Research Group, said in a statement. The opioid in question is a highly potent, and risky drug that has more risks than benefits in health-care.

The statement noted the benefit the drug could have for soldiers injured on the battlefield. AcelRx Pharmaceticals, maker of the drug, explains that, in many care settings-including battlefield settings-patients may not have readily available access to intravenous (IV) treatments for pain, and intramuscular injections (currently the standard of care for battlefield patients) are not as effective as IV options at providing timely relief, and may not be effective in cases of severe trauma that involves hypovolemic shock.

Brown, four U.S. Senators and the advocacy group Public Citizen have predicted that Dsuvia will be diverted to illicit use and cause more opioid overdose deaths. For this reason, the Department of Defense (DoD) worked closely with the sponsor on the development of this new medicine.

The pills contain sufentanil, a chemical cousin of the opioid fentanyl.

AcelRx Pharmaceuticals, in a statement, said the drug was long in the making.

"I am very disappointed with the decision of the agency to approve Dsuvia". But Raeford Brown, a professor of anesthesiology and pediatrics at the University of Kentucky who chairs the committee, then took the rare step of publicly condemning that decision and urging the FDA to reject the drug. Company executives said they expect to launch Dsuvia in the first quarter of 2019.

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He then berated Acosta for the way he questioned White House press secretary Sarah Huckabee Sanders in briefings. You are a rude bad person. "You should not be working for CNN". "It was not an invasion", Acosta explained.

Macron said, "we need a Europe that defends itself better alone, without just depending on the United States". "Faced with a Russian Federation at our frontiers that has shown that she can be a threat", M.

The German star has not been convincing for his manager Pep Guardiola after his slow start to this Premier League season. He added the following about him not being given gametime at the start of the season: "I have not been anxious at all".

After the first of the late restarts, Harvick was on the inside and was able to keep Blaney from clearing him on the backstretch. He then recovered from a pass-through penalty and a loose tire, managing to fight his way back to a ninth place finish.

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Whilst the odds are stacked against Bellew, he is adamant he can pull off the upset and take home the titles. You need to inundate and immerse yourself by sparring this way and I think that's what Tony Bellew has done.

Mourinho used Simao Valente, an assistant professor at the University of Lisbon and expert in the Portuguese language. However, United successfully contested the original charge.

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